Vironova Biosafety is a contract research organization (CRO) specialized in performing viral clearance studies for biological drugs.
Vironova Biosafety is a contract research organization (CRO) specialized in viral clearance studies for biological drugs.
We offer viral clearance studies in BSLII and BSLIII certified cell and virus laboratories, in compliance with good laboratory practice (GLP) principles and are GLP certified since 2011. Our services range from early R&D to market release. Literature-based viral risk assessment is also offered by our experts with extensive scientific and regulatory experience.
Our office and laboratories are in central Stockholm. Our customers are found worldwide.
Viral clearance is performed before Phase I and Phase III clinical trials. For the early phase, testing should be performed with one enveloped virus (preferable a retrovirus) and one small non-enveloped model virus.
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Our risk assesment experts assist you with consultative services regarding viral safety, such as: viral risk assessment reports, advice on viral reduction strategies, down-scaling strategies, and on regulatory requirements
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PCR is a method where a specific DNA sequence, the target, is amplified by a primer pair. The amplification can be detected by a sequence specific probe coupled to a fluorofor and its quencher.
Learn moreOur experts will tailor a quotation based on your specific project.
Request a free quote from us and one of our biosafety experts will contact you to initiate the discussion.
Vironova Biosafety operates in compliance with OECD GLP guidelines and is included in the regular inspection plan of the Swedish Board for Accreditation and Conformity Assessment (SWEDAC).
As stated in ICH Q5A, manufacturers of biologics are required to prove the viral removal and/or inactivation efficacy in their manufacturing process, and viral clearance studies are required to be performed in compliance with GLP principles.
The Vironova Biosafety team have a broad research background and experience of a wide range of biologics. We can help you to plan a specific study or solve a tricky problem. Whatever your need, you can contact Vironova Biosafety by sending an e-mail to info@vironova.com or by sending us an email through our contact us page which can be reach with the button below.
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